AzTrials
AzTrials

Heart FailurePhase 3NCT00007683

Warfarin and Antiplatelet Therapy in Chronic Heart Failure

A Phase 3 study testing Warfarin titrated to an INR of 2.5-3.0, Aspirin and Clopidogrel 75 in people with Heart Failure, run by US Department of Veterans Affairs at 134 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Warfarin titrated to an INR of 2.5-3.0, Aspirin and Clopidogrel 75
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,587 participants
Where
134 sitesin 3 countries
Study dates
Oct 1998to Dec 2004
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with NYHA class II, III, or IV and left ventricular ejection fractions less than or equal to 35%, on an ACE inhibitor (unless not tolerated) and on a diuretic.

Who cannot join

None listed.

Trial locations and contacts

134 sites in 3 countries.

134 sites in 3 countries

United States79 sites

  • VA Stratton Medical Center, Albany

    Albany, New York, 12208

  • VA Ann Arbor Healthcare System

    Ann Arbor, Michigan, 48113

  • Florida Cardiovascular Research

    Atlantis, Florida, 33462

  • VA Medical Center, Augusta

    Augusta, Georgia, 30904

  • VA Medical Center, Bay Pines

    Bay Pines, Florida, 33708

  • Edith Nourse Rogers Memorial Veterans Hospital, Bedford

    Bedford, Massachusetts, 01730

  • VA Gulf Coast Veterans Health Care System, Biloxi

    Biloxi, Mississippi, 39531

  • VA Medical Center, Birmingham

    Birmingham, Alabama, 35233

  • VA Boston Healthcare System, Brockton Campus

    Brockton, Massachusetts, 02301

  • VA Western New York Healthcare System at Buffalo

    Buffalo, New York, 14215

  • Univ of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-7075

  • Jesse Brown VAMC (WestSide Division)

    Chicago, Illinois, 60612

  • VA Medical Center, Cincinnati

    Cincinnati, Ohio, 45220

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106

  • Chalmers P. Wylie VAOPC

    Columbus, Ohio, 43203-1278

  • VA Medical Center, Dayton

    Dayton, Ohio, 45428

  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

  • VA Eastern Colorado Health Care System, Denver

    Denver, Colorado, 80220

  • Cardiology Associates of Derby, P.C.

    Derby, Connecticut, 06418

  • John D. Dingell VA Medical Center, Detroit

    Detroit, Michigan, 48201

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242

  • VA Medical Center, Durham

    Durham, North Carolina, 27705

  • VA Medical Center, Fargo

    Fargo, North Dakota, 58102

  • New York Hospital Medical Center Of Queens

    Flushing, New York, 11355

  • VA Black Hills Health Care System, Fort Meade

    Fort Meade, South Dakota, 57741

  • VA Central California Health Care System, Fresno

    Fresno, California, 93703

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida, 32608

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0553

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06120

  • Margaret Pardee Memorial Hospital

    Hendersonville, North Carolina, 28739

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141-5000

  • Michael E. DeBakey VA Medical Center (152)

    Houston, Texas, 77030

  • VA Medical Center, Huntington

    Huntington, West Virginia, 25704

  • River Cities Cardiology

    Jeffersonville, Indiana, 47130

  • VA Medical Center, Kansas City MO

    Kansas City, Missouri, 64128

  • Watson Clinic LLP

    Lakeland, Florida, 33805

  • Lincoln Division VA Nebraska Western IA HCS

    Lincoln, Nebraska, 68510

  • VA Medical Center, Loma Linda

    Loma Linda, California, 92357

  • Wlliam S. Middleton Memorial Veterans Hospital, Madison

    Madison, Wisconsin, 53705

  • North Shore University Hospital

    Manhasset, New York, 11030

  • VA Medical Center, Martinsburg

    Martinsburg, West Virginia, 25041

  • VA Medical Center, Memphis

    Memphis, Tennessee, 38104

  • Brevard Cardiology

    Merritt Island, Florida, 32952

  • VA Medical Center, Miami

    Miami, Florida, 33125

  • VA Medical Center, Minneapolis

    Minneapolis, Minnesota, 55417

  • VA Medical Center, Muskogee

    Muskogee, Oklahoma, 74401

  • VA Medical Center

    Nashville, Tennessee, 37212-2637

  • New York Harbor HCS

    New York, New York, 10010

  • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

    No. Little Rock, Arkansas, 72114-1706

  • VA Medical Center, Northport

    Northport, New York, 11768

  • VA Medical Center, Oklahoma City

    Oklahoma City, Oklahoma, 73104

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1290

  • Cardiology Consultants - Pensacola

    Pensacola, Florida, 32501

  • Heart Care Midwest

    Peoria, Illinois, 61603

  • VA Medical Center, Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Carl T. Hayden VA Medical Center

    Phoenix, Arizona, 85012

  • VA Pittsburgh Health Care System

    Pittsburgh, Pennsylvania, 15240

  • VA Medical Center, Portland

    Portland, Oregon, 97201

  • VA Medical Center, Providence

    Providence, Rhode Island, 02908

  • VA Sierra Nevada Health Care System

    Reno, Nevada, 89502

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • VA Salt Lake City Health Care System, Salt Lake City

    Salt Lake City, Utah, 84148

  • VA South Texas Health Care System, San Antonio

    San Antonio, Texas, 78229

  • VA Medical Center, San Francisco

    San Francisco, California, 94121

  • VA Greater Los Angeles HCS, Sepulveda

    Sepulveda, California, 91343

  • Overton Brooks VA Medical Center, Shreveport

    Shreveport, Louisiana, 71101

  • DUCCS Research of South Boston

    South Boston, Virginia, 24592

  • Bay State Medical Center

    Springfield, Massachusetts, 01104

  • VA Medical Center, St Louis

    St Louis, Missouri, 63106

  • VA Medical Center, Syracuse

    Syracuse, New York, 13210

  • University Cardiology Consultants

    Tamarac, Florida, 33321

  • James A. Haley Veterans Hospital, Tampa

    Tampa, Florida, 33612

  • William Beaumont Hospital

    Trey, Michigan, 48095

  • Southern Arizona VA Health Care System, Tucson

    Tucson, Arizona, 85723

  • Cardiovascular Consultants, Walnut Creek

    Walnut Creek, California, 94598

  • VA Medical Center, DC

    Washington D.C., District of Columbia, 20422

  • VA Connecticut Health Care System (West Haven)

    West Haven, Connecticut, 06516

  • VA Greater Los Angeles Healthcare System, West LA

    West Los Angeles, California, 90073

Other trials in United States

Canada28 sites

  • Ajax and Pickering General Hospital

    Ajax, Ontario, L1S 7K8

  • Bramptom, Research Associates

    Brampton, Ontario, L6V 1B4

  • Cardiology Consultants

    Calgary, Alberta, T2E 7C5

  • Alder Medical Centre

    Campbell River, British Columbia, V9W 6X8

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Com. Hospital and Health Centre

    Edmonton, Alberta, T6L 5X8

  • Neureka Research Inc. Willett Green Millr Cntr

    Greater Sudbury, Ontario, P3E 6B4

  • Queen Elizabeth II HSC

    Halifax, Nova Scotia, B3H 3A7

  • Hamilton Health Sciences Corp. - General Div

    Hamilton, Ontario, L8L 2X2

  • St. Joseph's Hospital

    Hamilton, Ontario, L8P 3B6

  • London HSC - University Campus

    London, Ontario, N6A 5A5

  • Invascor Clinical Research Inc.

    Longeuil, Quebec, J4N 1E1

  • Credit Valley Hospital Research Associates

    Mississauga, Ontario, L5M 2N1

  • Cardiology Clinic - Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Niagara Falls Medical Center

    Niagara Falls, Ontario, L2E 7H1

  • North Shore Cardiology Laboratory

    North Vancouver, British Columbia, V7L 2P7

  • Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Regina General Hospital

    Regina, Saskatchewan, S4P 0W5

  • Etobicoke General Hospital

    Rexdale, Ontario, M9V 4B8

  • St. Paul's Hospital

    Saskatoon, Saskatchewan, S7K 0Z9

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Cardiology Research Associates

    Scarborough Village, Ontario, M1S 4V5

  • Surrey Memorial Hospital - Cardiology

    Surrey, British Columbia, V3V 1Z2

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • Hotel-Dieu D'Artabaska

    Victoriaville, Quebec, G6P 6N2

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Health Sciences Centre - Cardiology Research

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

United Kingdom27 sites

  • Barnsley District General

    Barnsley, South Yorkshire, S75 2EP

  • Royal Victoria Hospital

    Belfast, Antrim, BT12 6BA

  • Blackpool Victoria Hospital

    Blackpool, Lancashire, FY3 8NR

  • Bridlington and District Hospital

    Bridlington, Bridlington, YO16 4QP

  • Cardiology Research Unit Sussex House

    Brighton, Sussex, BN2 1ES

  • Castle Hill Hospital

    Cottingham, Hull, HU16 5JG

  • Derbyshire Royal Infirmary

    Derby, Derby, DE1 2QY

  • Derriford Hospital

    Devon, Devon, PL6 8DH

  • Glasgow Western Infirmary

    Glasgow, Glasgow, G12 8QQ

  • Princess of Wales Hospital (Grimsby)

    Grimsby, South Humberside, DN33 2BA

  • Northwick Park Hospital and Institue for Medical R

    Harrow, Middlesex, HA1 3UJ

  • King Geroge Hospital

    Ilford, Essex, IG3 8YB

  • St. James' University Hospital

    Leeds, West Yorkshire, LS9 7TF

  • St. Thomas' Hospital

    London, London, SE1 7EH

  • Luton and Dunstable Hospital

    Luton, Beds, LU4 0DZ

  • South Cleveland Hospital

    Middlesbrough, Cleveland, TS4 3BW

  • Royal Alexandra Hospital

    Paisley, Renfrewshire, PA2 9PN

  • Newham General Hospital

    Plaistow, London, E13 8SL

  • Pontefract General Infirmary

    Pontefract, West Yorshire, WF8 1PL

  • Scunthorpe General Hospital

    Scunthorpe, North Lincolnshire, DN15 7BH

  • Selly Oak Hospital

    Selly Oak, Birmingham, B29 6JD

  • Northern General Hospital

    Sheffield, Yorkshire, S5 7AU

  • Stepping Hills Hospital

    Stockport, Cheshire, SK2 7JE

  • Torbay District General

    Torbay, Devon, TQ2 7AA

  • Pinderfields General Hospital

    Wakefield, United Kingdom, WF1 4DG

  • Wythenshawe Hospital

    Wythenshawe, Manchester, M23 9LT

  • York District Hospital

    York, North Yorkshire, YO3 7HE

Other trials in United Kingdom

About this study

Official title: CSP #442 - Warfarin and Antiplatelet Therapy Study in Patients With Congestive Heart Failure (WATCH)

Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).

Read the detailed description

Primary Hypothesis: The hypothesis to be tested is whether aspirin, warfarin, and clopidogrel are equally effective in the treatment of patients with symptomatic CHF and reduced ejection fraction.

Secondary Hypothesis: If one therapy proves to be superior with regard to outcomes, what is the cost of this benefit? Can subsets of patients be identified who benefit more from a specific approach to antithrombotic therapy?

Intervention: The three treatment regimens are:

  1. Open-label Warfarin titrated to an INR of 2.5-3.0;
  2. Double blind aspirin 162 mg once daily;
  3. Double blind clopidogrel 75 mg once daily.

Primary Outcomes: Any death (all causes), non-fatal stroke, non-fatal MI.

Study Abstract: Whether patients with chronic heart failure (CHF) should be anticoagulated is one of the oldest unresolved questions in cardiovascular therapeutics. Some authorities do not recommend anticoagulation for CHF patients in sinus rhythm, others recommend anticoagulation in patients with primary cardiomyopathy, and still others consider it more appropriate in patients with coronary artery disease (CAD). This absence of consensus reflects the lack of evidence in this area and different outlooks on the objectives of such therapy (e.g., prevention of arterial emboli or reduction in vascular events).

The original target sample size was 4,500 over a 3 year enrollment period with a 2 year follow-up. This sample size yielded 90% power to detect a relative difference of 20% between treatment groups. The sample size was later amended to 1,500 over a 30 month enrollment period with a 12 month follow-up. The reduced sample size yielded 85% to detect a between treatment difference of 30%. This change became effective in March 2002.

This clinical trial enrolled 1,587 patients in 142 medical centers; VA and non-VA centers in the U.S., and medical centers in the United Kingdom and Canada. Patients were randomly and equally allocated to the 3 treatments: warfarin (administered open-label), aspirin and clopidogrel (the latter two administered double-blind). The study was conducted over a 3.5 year period, with a 2.5 year enrollment phase.

Patients with NYHA class II, III, or IV and left ventricular ejection fractions less than or equal to 35% on an ACE inhibitor (unless not tolerated) and a diuretic were entered. The primary end point is the composite of death from any cause, non-fatal MI, and non-fatal stroke. All-cause mortality is the secondary end point.

The WATCH design paper has been published in the Journal of Cardiac Failure. Preliminary results were presented at the meeting of the American College of Cardiology in New Orleans on March 9, 2004. There were no significant differences between the treatment groups for the primary endpoints. The paper with final results is being prepared.

Conditions
Heart Failure
Being tested
Warfarin titrated to an INR of 2.5-3.0, Aspirin, Clopidogrel 75
Keywords
aspirin, clopidogrel, embolic events, Left ventricular ejection fraction less than or eq, NYHA Class II, III or IV CHF, symptomatic CHF, warfarin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Warfarin titrated to an INR of 2.5-3.0Drug

    anticoagulation (administered without blinding) titrated to a target INR of 2.5 to 3.0, monitored by measurements at 6 week intervals after initial titration and stabilization.

  • AspirinDrug

    an antiplatelet agent whose mechanism is inhibition of thromboxane, a platelet activator) administered in a double blind manner.

  • Clopidogrel 75Drug

    (an antiplatelet agent whose mechanism is ADP inhibition) administered in a double blind manner)

Study groups in NCT00007683
Study groupRoleWhat they receive
1Active comparatorWarfarin Titrated to an INR of 2.5-3.0
Receives: Drug: Warfarin titrated to an INR of 2.5-3.0
2Active comparatorAspirin 182 mg
Receives: Drug: Aspirin
3Active comparatorClopidogrel 75 mg
Receives: Drug: Clopidogrel 75

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke

    The primary safety end point was major bleeding episodes, defined as bleeding episodes leading to death or disability (including loss of neurological or special senses function), requiring surgical intervention, or associated with an acute decline of hemoglobin 2gm/dl or transfusion of >1 U packed red cells or whole blood.

    Measured: 30 months intake; 12-42 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2001 (estimated)
  2. Study startOct 1998
  3. Primary completionJul 2003
  4. Study completionDec 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,587 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00007683
Sponsor's protocol ID
442
Status last verified
Jun 2011
First submitted
29 Dec 2000
Last updated
16 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Massie BM, Krol WF, Ammon SE, Armstrong PW, Cleland JG, Collins JF, Ezekowitz M, Jafri SM, O'Connor CM, Packer M, Schulman KA, Teo K, Warren S. The Warfarin and Antiplatelet Therapy in Heart Failure trial (WATCH): rationale, design, and baseline patient characteristics. J Card Fail. 2004 Apr;10(2):101-12. doi: 10.1016/j.cardfail.2004.02.006.

    PubMed 15101020

  • Massie BM, Collins JF, Ammon SE, Armstrong PW, Cleland JG, Ezekowitz M, Jafri SM, Krol WF, O'Connor CM, Schulman KA, Teo K, Warren SR; WATCH Trial Investigators. Randomized trial of warfarin, aspirin, and clopidogrel in patients with chronic heart failure: the Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial. Circulation. 2009 Mar 31;119(12):1616-24. doi: 10.1161/CIRCULATIONAHA.108.801753. Epub 2009 Mar 16.

    PubMed 19289640

  • Patterson ME, Grant WC, Glickman SW, Massie BM, Ammon SE, Armstrong PW, Cleland JG, Collins JF, Teo KK, Schulman KA, Reed SD. Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation. J Card Fail. 2009 Dec;15(10):819-27. doi: 10.1016/j.cardfail.2009.07.004. Epub 2009 Aug 21.

    PubMed 19944357

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Warfarin titrated to an INR of 2.5-3.0, Aspirin and Clopidogrel 75 in people with Heart Failure, run by US Department of Veterans Affairs at 134 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

acomposite of mortality, nonfatal myocardial infarction and nonfatal stroke (time frame: 30 months intake; 12-42 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00007683, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in